Evaluating bronchoalveolar lavage and sequencing for diagnosing pneumonia from immune checkpoint inhibitors
Prospective Study on the Efficacy and Safety of Bronchoalveolar Lavage Combined With Pathogen Metagenomic Sequencing Technology in the Diagnosis of Immune Checkpoint Inhibitor Associated Pneumonia
Nanfang Hospital, Southern Medical University · NCT06192303
This study is testing if a special lung procedure and advanced testing can help doctors accurately diagnose pneumonia caused by immune checkpoint inhibitors in patients who aren't getting better with regular treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06192303 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of using bronchoalveolar lavage combined with pathogen metagenomic sequencing to diagnose immune checkpoint inhibitor associated pneumonia (CIP). Given the challenges in distinguishing CIP from other pulmonary conditions, this observational study aims to improve diagnostic accuracy and reduce misdiagnosis. Participants will undergo bronchoalveolar lavage, and the samples will be analyzed using advanced sequencing technology to identify pathogens. The study focuses on patients who show pneumonia symptoms but have not responded to standard anti-infection treatments.
Who should consider this trial
Good fit: Ideal candidates are immunosuppressed individuals aged 18 to 75 who exhibit pneumonia symptoms and have not responded to empirical anti-infection treatment.
Not a fit: Patients without symptoms of pneumonia or those who do not meet the age and immunosuppression criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and better treatment outcomes for patients suffering from CIP.
How similar studies have performed: While there is limited large-scale prospective research on this specific approach, the use of bronchoalveolar lavage and metagenomic sequencing has shown promise in other diagnostic contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntarily sign an informed consent form; 2. Age range from 18 to 75 years old, regardless of gender; 3. Immunosuppressive host; 4. Symptoms, signs, or imaging signs of pneumonia are visible, and empirical anti infection treatment is ineffective. Exclusion Criteria:
Where this trial is running
Guangzhou, Guangdong
- Southern Medical University Nanfang Hospital — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Xintong Huang
- Email: 1556807596@qq.com
- Phone: 8619355230761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immune Checkpoint Inhibitor Associated Pneumonia